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OpenTrials
Completed

NCT Number: NCT07225647

A Study to Assess the Effect of Food on the Drug Levels of Admilparant

The purpose of this study is to assess the effect of food on the drug levels of Admilparant

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Key information

Conditions

Healthy Participants

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0002, Lenexa, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have a body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
  • Participants must have a body weight of ≥ 50 kg for males and ≥ 45 kg for females at screening.

Exclusion criteria

  • Participants must not have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  • Participants must not have had any previous exposure to Admilparant.
  • Participants must not have a history of any severe drug allergy or drug reaction (such as anaphylaxis or hepatotoxicity).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Admilparant

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 13 days

  2. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to 13 days

  3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to 13 days

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 13 days

  2. Terminal half-life (T-HALF)

    Time frame: Up to 13 days

  3. Apparent total body clearance (CLT/F)

    Time frame: Up to 13 days

  4. Apparent volume of distribution (Vz/F)

    Time frame: Up to 13 days

  5. Number of participants with adverse events (AEs)

    Time frame: Up to 13 days

  6. Number of participants with a change in clinical laboratory values

    Time frame: Up to 13 days

  7. Number of participants with a change in vital sign measurements

    Time frame: Up to 13 days

  8. Number of participants with a change in physical examination results

    Time frame: Up to 13 days

  9. Number of participants with a change in 12-lead electrocardiogram (ECG) results

    Time frame: Up to 13 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-Label, Randomized, Two-part Study in Healthy Participants to Assess the Food Effect on the Pharmacokinetics of Admilparant To-Be-Marketed Tablet Formulations

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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